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Ologen (OculusGen)-Glaucoma and Pterygium Historical Control Study in China Beijing Hospital

This study has been completed.
Sponsor:
Information provided by:
Pro Top & Mediking Company Limited
ClinicalTrials.gov Identifier:
NCT00320762
First received: May 1, 2006
Last updated: May 21, 2008
Last verified: May 2008
History of Changes
  Purpose

The purpose of this study is to determine whether the OculusGen Collagen Matrix is effective and safe to implant as an aid of glaucoma and pterygium surgeries.


Condition Intervention Phase
Glaucoma
Pterygium
 Device: OculusGen Biodegradable Collagen Matrix Implant
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of the Safety and Effectiveness of the Ologen (OculusGen) Collagen Matrix Implant as an Aid in Glaucoma and Pterygium Surgery

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Pro Top & Mediking Company Limited:

Primary Outcome Measures:
  • the effectiveness via the reduction of IOP and the incidence of pterygium recurrence [ Time Frame: 180 day ]

Secondary Outcome Measures:
  • the safety via the incidence of complications and adverse events. [ Time Frame: 180 day ]

Estimated Enrollment: 60
Study Start Date: January 2006
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Detailed Description:

ologen (OculusGen) Collagen Matrix is a porous, scaffold matrix. It is to be implanted on the top of the scleral flap and beneath the conjunctiva and Tenon's capsule at the end of trabeculectomy. The pores in the scaffold matrix range from 20 to 200µm, a size that is suitable for fibroblasts to grow randomly, through the body of the matrix without causing scarring. The space occupied by the collagen matrix scaffold creates room for the development of a filtration bleb. Immediately after implantation, the collagen matrix is absorbed with the aqueous humor that brings a certain pressure press on the top of the scleral flap which makes the dynamic balance for the aqueous system keep the IOP in the right side. The collagen matrix is bio-degraded within 90 days and will leave a physiologic space for the filtration bleb to facilitate control of intraocular pressure (IOP).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18 years or over
  • Patient able to cooperate with study procedures and able to perform tests reliably
  • Patient willing to sign informed consent
  • Patient able and willing to complete postoperative follow-up requirements
  • Glaucoma: one/both eye(s) is/are affected by glaucoma
  • Pterygium: patient with pterygium

Exclusion Criteria:

  • Known allergic reactions to collagen
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00320762

Locations
China
Beijing Hospital
Beijing, China, 100730
Sponsors and Collaborators
Pro Top & Mediking Company Limited
Investigators
Principal Investigator: Hong Dai, MD Beijing Hospital
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00320762     History of Changes
Other Study ID Numbers: Mediking0501-2
Study First Received: May 1, 2006
Last Updated: May 21, 2008
Health Authority: China: Food and Drug Administration

Keywords provided by Pro Top & Mediking Company Limited:
Glaucoma
Pterygium
collagen matrix
OculusGen
trabeculectomy
 Anti scarring
pterygium recurrence
tissue engineering
Aeon Astron

Additional relevant MeSH terms:
Glaucoma
Pterygium
Ocular Hypertension
Eye Diseases
Conjunctival Diseases

ClinicalTrials.gov processed this record on May 16, 2013